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Integrated Care for Opioid Use Disorder and HIV (IMPACT Trial)

N/A

Waitlist Available

Led By Frederick Altice, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months up to 24 months

Awards & highlights

IMPACT Trial Summary

This trial will compare the outcomes of 1,350 people who inject drugs receiving methadone maintenance treatment at specialized clinics with those receiving treatment at primary care clinics. The trial will use a stratified, phase-in, cluster-controlled design over 24 months, and will examine the contribution of client, clinician and organizational factors that contribute to the composite primary outcome and individual secondary outcomes. A cost-effectiveness analysis will be conducted to compare the integrated HIV/MMT primary care model with the specialized MMT clinic model.

Who is the study for?

This trial is for people who inject drugs (PWID), are interested in methadone maintenance treatment (MMT), and meet the criteria for Opioid Dependence according to DSM-V. Participants must be willing to give consent.Check my eligibility

What is being tested?

The study tests integrating HIV services with addiction treatment in primary care clinics versus specialty addiction clinics. It involves a randomized controlled design, comparing health outcomes and quality of life over 24 months among 1,350 PWIDs across different settings.See study design

What are the potential side effects?

Since this trial focuses on service integration rather than a specific medical intervention, side effects are not the main concern; however, typical risks associated with MMT may include nausea, drowsiness, or mood changes.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy

Secondary outcome measures

Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy

Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy

Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy

IMPACT Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ECHO-IC/QI-enhanced primary care clinicExperimental Treatment1 Intervention

Group II: Specialty Addiction ClinicActive Control1 Intervention

Group III: ECHO-IC/QI-enhanced primary care clinic with Pay for PerformanceActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,210 Total Patients Enrolled

Ukrainian Institute on Public Health PolicyOTHER

6 Previous Clinical Trials

3,121 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,617,175 Total Patients Enrolled

Media Library

Integration of HIV and PWID services Clinical Trial Eligibility Overview. Trial Name: NCT04927091 — N/A

Opioid Use Disorder Research Study Groups: ECHO-IC/QI-enhanced primary care clinic, Specialty Addiction Clinic, ECHO-IC/QI-enhanced primary care clinic with Pay for Performance

Opioid Use Disorder Clinical Trial 2023: Integration of HIV and PWID services Highlights & Side Effects. Trial Name: NCT04927091 — N/A

Integration of HIV and PWID services 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927091 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this investigation still ongoing?

"Clinicaltrials.gov displays that this research project, which was first launched on May 1st 2017, is actively recruiting volunteers. It has recently been updated as of August 12th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine

2017. "Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927091.

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